MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC MICRUSPHERE 18 - PLATINUM MICROCOIL; CNV DCS COILS

Catalog Number SPH18090020

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2013

Event Type  malfunction  

Event Description

It was reported that the outer package of the micrusphere 18 platinum microcoil 9 mm x 15.3 cm was noted to be damaged when removed from the shipping box.It was reported that all of the other items in the shipping box were fine, with no damage.It was unknown if there was anything unusual about the way things were packed in the shipping box and it could not be confirmed whether there was damage to the shipping box.It was reported that there was no evidence of loss of product sterility or actual product damage; however, they did not want to risk that there might be damage to the device inside so the device was returned for analysis.The preliminary product analysis completed on (b)(6) 2014 revealed that there was inner pouch seal damage that breached the sterile field caused by the severe external damage to the box.Damage to the inner seal was observed at both the chevron side and its opposite side.With additional investigation, identification of the specific shipment involved is not available.

Manufacturer Narrative

(b)(6).There is no patient information provided since this packaging complaint was discovered prior to any intended procedure.Complaint conclusion: product analysis: the external surface of the returned device box has severe compression damage diagonally; additionally, the outside label is torn.The inner pouch has seal damage on all four sides with two seals found to be breached.Based on the analysis there is evidence that external force was applied diagonally to the box which caused the hoop inside the box to produce creep damage to the inner pouches sterile seals which caused breach of the seals in two locations.There is evidence of seal transfer indicating that the pouch had been fully sealed; the breach was caused by mechanical forces from the hoop.The exact circumstances of how and where this outer box damage occurred, which caused inner pouch seal compromise, cannot be determined.There is no evidence that the damage occurred at the manufacturing facility as all boxes and pouches are inspected during final packaging.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Conclusion: the reported damage to the outer box was confirmed.Inner seal breach was also confirmed through analysis of the returned device.Based on the analysis, the cause of the damage to the inner pouch seals was caused by application of external force to the box.It was not possible to determine when this damage occurred or root; however, there is no evidence that the damage is related to the device/packing design or manufacturing process.Therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.

• Brand Name: MICRUSPHERE 18 - PLATINUM MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3613063
• MDR Text Key: 4094504
• Report Number: 1226348-2014-00024
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2017
• Device Catalogue Number: SPH18090020
• Device Lot Number: C11809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1